Positive Data Reported From Late-Stage Study of Dolutegravir vs. Darunavir in Adults With HIV-1
Dolutegravir provides significantly greater virologic suppression (September 12)
Positive results have been reported from the phase IIIb/IV open-label FLAMINGO trial, which compared once-daily regimens containing dolutegravir (Tivicay, ViiV Healthcare) 50 mg with once-daily regimens containing a protease inhibitor (darunavir 800 mg boosted with ritonavir 100 mg) in treatment-naïve adults with HIV-1. Both treatment arms were administered with investigator-selected dual nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs).
At 48 weeks, a significantly greater proportion of the patients treated with the dolutegravir regimen (90%) were virologically suppressed (HIV-1 RNA < 50 copies/mL, the primary endpoint of the study) compared with those treated with the darunavir regimen (83%; P = 0.025).
Comparing the dolutegravir and darunavir arms, rates of virologic non-response were 6% versus 7%, respectively; rates of treatment withdrawal due to adverse events were 1% versus 4%; and rates of treatment withdrawal for other reasons (such as protocol deviation, lost to follow-up, or consent withdrawn) were 2% versus 5%. There were no treatment-emergent primary viral mutations leading to treatment resistance in either study arm.
The new data were presented at the 53rd International Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Denver, Colorado.
FLAMINGO, a phase IIIb/IV study, follows four phase III trials that examined the efficacy and safety of dolutegravir. It is the third study in treatment-naïve adults with HIV-1. Data from the SPRING-2, SINGLE, and VIKING-3 trials were announced in 2012, and data from the SAILING trial were announced in 2013. These four studies formed the basis of the registration package leading to the FDA approval of Tivicay (dolutegravir) on August 12, 2013.
Source: ViiV Healthcare; September 12, 2013.